Dose Range Finding Study for Effects of Marine Protein Hydrolysate as Dietary Supplement in Elderly Active Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Glucose
研究概览
简要总结
The aim of this study is to investigate the potential effect of different doses of MPH supplement on glucose metabolism, hunger and appetite hormones.
详细描述
The potential use of marine protein hydrolysates (MPH) as a supplement with similar or better health benefits than a regular white fish meal, can be regarded both cost-effective, environmental friendly and sustainable.
The aim of this study is to investigate the potential effect of increasing/different doses of MPH supplement on glucose metabolism, hunger and appetite hormones in healthy elderly, to provide a basis for the optimalization of the daily dose for further use of MPH in clinical study protocols in elderly patients with sarcopenia, other inflammatory conditions or abnormal glucose metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Body mass index (BMI) 20-30 kg/m2
排除标准
- •Suspected allergies against fish or shellfish
- •Low or unstable blood pressure
- •Diabetes mellitus pharmacologically treated
- •Chronic diseases or therapies that are likely to interfere with the evaluation of study results such as known inflammation or muscle loss
- •Acute infections (may be reconsidered for inclusion at a later time)
- •Substance misuse
- •Inability or unwillingness to comply with the requirements of study procedures
研究组 & 干预措施
marine protein hydrolysate 1234
Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with up to 7 days wash-out in between. Random sequence of arms.
干预措施: marine protein hydrolysate 1234 (Dietary Supplement)
marine protein hydrolysate 2134
Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with up to 7 days wash-out in between. Random sequence of arms.
干预措施: marine protein hydrolysate 2134 (Dietary Supplement)
marine protein hydrolysate 3124
Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with with up to 7 days-out in between. Random sequence of arms.
干预措施: marine protein hydrolysate 3124 (Dietary Supplement)
marine protein hydrolysate 4123
Daily intake at breakfast of supplementary marine protein hydrolysate (MPH) equivalent to 10, 20, 30 or 40 mg per kg bodyweight during 1 week, followed by 3 similar cycles with other MPH dosages, with up to 7 days wash-out in between. Random sequence of arms.
干预措施: marine protein hydrolysate 4123 (Dietary Supplement)
结局指标
主要结局
Glucose
时间窗: A standardized meal, thereafter repeated measures every 20 minutes for 2 hours on day 7 in each intervention sequence
Postprandial glucose (mmol/L) curve on day 7 in each sequence
次要结局
- Insulin(After the standardized breakfast meal, repeated measure every 20 minutes for 2 hours, on day 7 in each intervention sequence)
- Hormon 1(At 6 different times point during a 2 hours period, on day 7 in each intervention sequence)
- Visual analogue scale (VAS)(Before breakfast on each study day (day 7 in each intervention sequence))
- KANE, symptom score(Two hours after breakfast on day 1 and 7 in each intervention sequence)